Agricultural Marketing Service (AMS) | National Organic Program (NOP)

National Organic Standards Board (NOSB) New Member Training Agenda

Wednesday, February 8, 2017

Location: USDA South Building - Washington DC - AMS Conference Room 3074

Tentative agenda revised: 2/6/2017

TRAINING AGENDA

Time Content Notes:

Slide presentation #/handout/web links

Online self-paced Organic 101 and 201 (Can review either online with 

voiceover, or in pdf)

http://www.ams.usda.gov/services/organiccertification/is-it-an-option

Online self-paced Sound & Sensible Organic Certification: 

o Overview video

The Road to Organic Certification

• Interactive Video: “The Road to Organic 

Certification”

8:30 AM Arrive at USDA South building - AMS Conference 

Room 3074. See instructions above for getting into 

the USDA building

9:00 - 9:30 AM AMS Welcome and Introductions AMS Administrator 

AMS Deputy Administrator McEvoy

9:30 - 10:00 AM National Organic Program Overview: Brief 

overview of NOP and its divisions, and where NOSB 

fits in.

Delivered by: Paul Lewis

PP_001 NOP Overview

Handouts: 

 001a_AMS Org Chart

 001b_NOP Org Chart

 001c_Program Handbook TOC

10:00 - 10:15 AM Brief Overview of Organic Foods Production Act 

(OFPA)

Delivered by: Mark Bradley

PP_002 OFPA

Handouts: 

 002_ OFPA (7 USC Ch 94 Organic)

10:15 - 10:45 AM Overview of USDA Organic Regulations 

Delivered by: Mark Bradley

PP_003 USDA OrganicRegs 

Handouts: 

 003_Organic Regulations TOC only

 

10:45 - 11:00 AM Break 

11:15 - 11:30 AM Brief Overview of Federal Advisory Committee Act 

(FACA):

Delivered by: Paul Lewis 

PP_004 FACA

 Link to FACA website

11:30 - 1:00 PM National List 

Delivered by: Lisa Brines

• Review National List petition process 

PP_005 NL Petition Process 

Handouts:

 005a_National List Petition 

 Guidelines - 2016

005b_NOP 3005-1 OFPA Exemption 

Checklist

005c_NOP 3005-2 Petition Guidelines 

Checklist
Agricultural Marketing Service (AMS) | National Organic Program (NOP)

National Organic Standards Board (NOSB) New Member Training Agenda

Wednesday, February 8, 2017

Location: USDA South Building - Washington DC - AMS Conference Room 3074

Tentative agenda revised: 2/6/2017

Time Content Notes:

Slide presentation #/handout/web links

11:30-1:00 PM 

continued

Sunset Process

Delivered by: Lisa Brines

• Review Sunset Process and Templates

PP_006 Sunset Process

Handouts:

 006a_NOP 5611 SunsetDates - Pg. 1 

 only

 006b_Sunset Process - 2013

1:00 PM Lunch - (USDA Cafeteria). Meet and greet with 

AMS/NOP staff over lunch. USDA cafeteria has a 

good variety of food options. Credit cards accepted.

2:00 – 2:30 PM Rulemaking

Delivered by: Shannon Nally Yanessa

• Key elements of rulemaking process (Getting a 

rule completed and through clearance (OGC and 

OBPA).

PP_007 Rulemaking Process

2:30 – 4:30 PM Proposals, Technical Reports, Public Comments 

Delivered by: Jessica Walden

• Best practices for writing proposals and 

recommendations 

• Best practices for evaluating technical reports 

• Best practices for analyzing public comments 

PP_008 BestPractices - Props Recs TRs 

PubComm

Handouts:

 008a_TR Samples Handout

 008b_Crops Pet Mat Prop Template 

 2-24-16

 008c_LS HS Pet Mat Prop Template 

 2-24-16 

4:30 – 5:30 PM NOP and NOSB Operational Guidelines (Charter, 

Nominations, Work agendas, Subcommittees, Public 

Meetings, FOIA Review, NOSB website). 

Delivered by: Jessica Walden, Michelle Arsenault 

PP_009 NOP NOSB OperatingGuides

Handouts:

 009a_NOSB Charter 2016

 009b_ 2016 NOSB Member Guide

 009c_Work Agenda example

 009d_SC AssignCallSched Jan2017

 009e_NOSB meeting agenda 

 example_Internal

5:30 – 6:00 PM Summary and Closing Discussion

Webinar 

Date: TBD

Content

30 minutes 

(Entire NOSB)

USDA Organic Working Group (OWG) and Secretary’s 

Organic Guidance - TBD

TBD

(1 hour)

(Entire NOSB)

Ethics and Conflict of Interest

Stuart Bender 

During March 10 ES call
National Organic Standards Board 

Training: 

National Organic Program Overview 

Agricultural Marketing Service | National Organic Program 

February 2017

USDA Agricultural Marketing Service | National Organic Program 1
Topics 

• NOP: Overview, Cross-Cutting Activities 

• Accreditation and International Activities 

• Compliance and Enforcement

• Standards 

USDA Agricultural Marketing Service | National Organic Program 2
The National Organic Program (NOP)

• Mission: 

Ensure the integrity of USDA organic products in the 

United States and throughout the world

• Vision: 

Organic Integrity from Farm to Table,

Consumers Trust the Organic Label 

• Core Role: 

Implement the Organic Foods Production Act and 

the USDA organic regulations 

National Organic Program | Agricultural Marketing Service 
What Does the Program Do? 

• Develop and maintain organic standards

• Accredit and oversee third party organic certifying 

agents, who review, inspect, and approve organic 

producers and handlers 

• Implement international organic trade agreements

• Investigate complaints of violations (example: 

uncertified farmer selling food as organic, selling 

conventional food as organic) 

• Manage the National Organic Standards Board

• Oversight Responsibility: 

81 certifying agents worldwide

31,000 + certified organic operations 

$43 billion in U.S. organic sales (2015)

National Organic Program | Agricultural Marketing Service 
Quick Facts About NOP 

• Staffing: 45 employees in three Divisions and the 

Office of the Deputy Administrator 

• Budget: 

FY 2012: $6.919 million

FY 2013: $6.369 million 

FY 2014 to 2016: $9 million

• NOP Leadership Team: 

Miles McEvoy – Deputy Administrator

Jennifer Tucker – Associate Deputy Administrator 

Paul Lewis – Standards Division Director 

Cheri Courtney – Accreditation and International Activities Div. Director 

Betsy Rakola – Compliance and Enforcement Division Director 

• MRP Leadership – Penny Zuck, USDA Organic Policy Advisor 

(Acting) 

National Organic Program | Agricultural Marketing Service 5
NOP Organization and Activities

National Organic Program

Office of Deputy Administrator

Miles McEvoy

Standards Division

Accreditation

& International 

Activities Division

Compliance &

Enforcement Division

National Organic 

Standards Board

• Rules, Guidance, 

Instructions, 

• National List

• Accreditation process

• Technical outreach

• International 

agreements

• Complaints

• Investigations

• Initiate enforcement 

actions 

• Market surveillance

• Communication

• National List • Administration 

recommendations

USDA Agricultural Marketing Service | National Organic Program 6
The Organic Stakeholder Community

There are three primary levels to the organic integrity framework. USDA’s National Organic Program establishes and enforces regulations, and accredits certifying agents. Agent certify operations, 

which include farmers and ranchers as well as processors and handlers. These operations sell to retailers and consumers. Feedback comes to the USDA through public comment to the NOP 

and the National Organic Standards Board.

National Organic Program | Agricultural Marketing Service 7
10 Points of Organic Integrity

1. Clear/enforceable standards

2. Communication

3. Transparency

4. Certification

5. Complaints

6. Penalties

7. Market surveillance

8. Unannounced inspections

9. Periodic residue testing

10. Continuous improvement
Key Cross-Cutting Activities 

• Policy Development

• Training and Outreach

• Communication 

• Collaboration: Across USDA and with Other 

Agencies 
Policy Development: NOP Document Matrix 

• NOP publishes a range of different types of 

documents for policy and outreach purposes. 

• The NOP Document Matrix is an internal tool that 

describes our different policy and outreach 

communication documents. 

• A brief overview of these document types follows. 

Often, NOSB recommendations will be considered 

against these options to determine best fit for 

implementation. 

USDA Agricultural Marketing Service | National Organic Program 10
NOP Document Matrix 

1. Rules

– Amend the USDA organic regulations

– Allow enforcement actions

– If “significant” require additional clearance

– Example: pasture rule, organic livestock and 

poultry practices rule

2. Interpretive Rules

– Explain NOP’s interpretation of statutes/rules or 

clarifies existing rules

– Have not been used by NOP, but could be in the 

future 

Home: USDA Organic Regulations
NOP Document Matrix 

3. Instructions

– Instruct certifying agents how to apply 

certification and accreditation requirements per 

205.501(a)(21)

– Aren’t announced via the Federal Register 

– Example: Conservation activity plan for organic 

system plans

4. Guidance Documents

– Provide options to satisfy regulatory requirements

– Support enforcement by referencing section of 

USDA organic regulations

– Example: Classification of materials

Home: Program Handbook

Home: Program Handbook
NOP Document Matrix

5. Policy Memos

– Formally communicate NOP policy decisions, but 

less formally than instructions/rules

– Are generally directed at certifying agents

– Aren’t announced via the Federal Register 

– Example: nanotechnology

6. Formal Letters

– Communicate non-policy information or requests

– Directed to certifying agents and NOSB

– Aren’t announced via the Federal Register

– Example: response to NOSB recommendations

Home: Program Handbook

Home: Public Correspondence page
NOP Document Matrix

7. Federal Register Notices

– Announce activities requiring legal notification 

– Example: NOSB meeting announcement, NOSB 

Call for Nominations

8. Newsletter Articles

– Highlight NOP announcements, provide status 

updates

– Aren’t announced via the Federal Register

– Example: organic livestock and poultry practices

Home: Rules/Notices Page

Home: About Us Page
NOP Document Matrix

9. NOP Organic Insider

– Announces all NOP documents and activities

– Aren’t announced via the Federal Register

– Examples: Recruiting announcements, new fact 

sheets, equivalency arrangement information, 

new policy documents and memos 

– Subscribe to receive email updates:

http://bit.ly/NOPOrganicInsider

Home: Insider archive
Training and Outreach

• Annual classroom training for NOP certifiers.

• Comprehensive webinar series for NOP auditors. 

• Visits with certifiers across the country to launch 

and discuss the “sound and sensible” initiative.

• Conference Outreach: Expo East, MOSES, Others

• Publications: New fact sheets, talking points, 

questions and answers, blogs, and other 

educational resources to support candidate and 

existing certified operations. 

USDA Agricultural Marketing Service | National Organic Program 16
NOP Communications 

• Email notification service 

• Quarterly Newsletter “Organic 

Integrity” 

• “Hot Topics” Website Postings

• Fact Sheets, Questions and Answers

• Briefings, Talking Points 

• Teleconferences and Webinars with 

Organic Community 

• National Organic Standards Board 

Public Meetings 

• Conference Presentations and 

Listening Sessions 

National Organic Program | Agricultural Marketing Service 17
Collaboration Across USDA and 

With Other Agencies 

• AMS Livestock, Poultry, and Seed Program: Economic analyses, technical 

reports, appeals reviews, accreditation audits

• AMS Science and Technology Program: Residue Testing Program 

• AMS Fruit and Vegetable Programs and Compliance and Analysis: 

Collaboration on investigations and enforcement actions; audits

• Food Safety Inspection Service and Natural Resources Conservation 

Service: Labelling coordination; streamline/reduce redundancies 

• Economic Research Service, NASS/Census of Agriculture, and National 

Agricultural Library: New data usage agreements 

• USDA Office of Chief Economist: Early review of NOP rules

• USDA Biotechnology Coordinating Group: NOP is AMS representative 

• NOP works with OIG, Department of Justice, DHS Customs and Border 

Protection, the Food and Drug Administration, the Environmental 

Protection Agency, and the TTB on both enforcement and regulatory issues. 

• Federal Trade Commission: Joint project to collect data on consumer 

perceptions of personal care products and textiles sold as organic. 

USDA Agricultural Marketing Service | National Organic Program 18
Topics 

• NOP: Overview, Cross-Cutting Activities 

• Accreditation and International Activities 

• Compliance and Enforcement

• Standards 

USDA Agricultural Marketing Service | National Organic Program 19
Accreditation Activities

• NOP oversees the work of 81 certifiers, which certify 

over 31,000 certified organic operations. 

– Work includes audits, audit report reviews, notices of 

noncompliance, corrective action reviews, 

responding to questions, updating list of certified 

operations 

– This work is done by Accreditation Managers, and a 

Lead Auditor 

– Supplemented by audit team in AMS Quality 

Assurance Divisions, Livestock and Seed Program 

USDA Agricultural Marketing Service | National Organic Program 20
International Trade

• Equivalency Agreements: 

– U.S.-Canada – Launched in 2009 

– U.S.-European Union – Launched in June 2012 

– Japan – Effective in January 2014

– Korea – Effective in July 2014

– Switzerland – Effective in July 2015

• Each country considers the other’s organic certification 

designation to be “equivalent” - equivalent standards, 

accreditation, certification and enforcement.

• The arrangement allows products produced, processed 

and certified to either country’s organic standards to be 

sold as organic in both countries

USDA Agricultural Marketing Service | National Organic Program 21
International Trade

• Recognition Agreements: 

– India, Israel, Japan, New Zealand

• NOP works closely with the Foreign Agricultural 

Service (FAS) and the U.S. Trade Representative 

(USTR).

• Allows a foreign government to accredit certifying 

agents in that country to the USDA organic 

standards. These foreign certifying agents are 

authorized to certify organic farms, processing 

facilities, and products to USDA organic standards 

so products can be imported as organic into the U.S.

USDA Agricultural Marketing Service | National Organic Program 22
High Priority Certification Issues to Address 

• Inconsistent certification process

• Recordkeeping focus and burden

• Expense of certification

• Burden of time that is involved in inspections 

and maintaining paperwork

• Some farms that comply with organic standards 

avoid certification.

The Sound and Sensible Initiative was established 

to start to address these issues. 
‘Sound + Sensible’ Principles

1. Efficient Processes: Eliminate bureaucratic processes 

that do not contribute to organic integrity. 

2. Streamlined Recordkeeping: Ensure that required 

records support organic integrity and are not a barrier 

to organic compliance.

3. Practical Plans: Support simple Organic System Plans 

that clearly capture organic practices. 

4. Fair, Focused Enforcement: Focus enforcement on 

willful, egregious violators; handle minor violations in a 

way that leads to compliance; and publicize how 

enforcement protects the market. 

5. Integrity First: Focus on factors that impact organic 

integrity the most, building consumer confidence.
Goal: Make Organic Certification:

Affordable, Accessible and Attainable for all 

operations

• Affordable – reasonable fees, reasonable 

compliance costs

• Accessible – certifiers and technical assistance 

available locally

• Attainable – Clear and understandable 

standards, plain language, reasonable record 

keeping requirements
AIA: Key Priorities in 2017 

• ACA Certifier Training: Spring 2017

• Accreditation Audits and Follow-up 

• Maintain existing recognition and equivalency 

arrangements – peer reviews, working groups 
Topics 

• NOP: Overview, Cross-Cutting Activities 

• Accreditation and International Activities 

• Compliance and Enforcement

• Standards 

USDA Agricultural Marketing Service | National Organic Program 27
Purposes of Enforcement

Purpose: To protect the integrity of the organic 

standards so as to facilitate commerce

• Maintain consumer confidence

• Ensure a fair market for the great majority of 

organic operations that operate in compliance with 

the law 

USDA Agricultural Marketing Service | National Organic Program 28
Compliance and Enforcement Division 

Key Activities: 

• Investigate complaints of alleged violations, work 

with operations to achieve compliance where 

possible and take enforcement actions as 

appropriate 

• Quarterly reports NOP Compliance & 

Enforcement/Appeals Summary

• Work with ACAs, State Programs and Federal 

partners on enforcement of OFPA and the USDA 

organic regulations 

• Lead enforcement-related policy development and 

outreach efforts 

USDA Agricultural Marketing Service | National Organic Program 29
Incoming Complaints: FY16
Compliance & Enforcement

FY 2015 and 2016

31

FY 2015 FY 2016

Compliance & Enforcement: Overall Summary 10/1/14-9/30/15 10/1/15-9/30/16

Incoming Complaints 549 499

Completed Complaints 390 357

Summary of Initial Actions Taken

Cease & Desist Orders 36 31

Notices of Warning 121 111

Civil Penalties Levied

Total Number 8 9

Total Amount $1,872,875 $397,750
Maintaining Integrity and Transparency

Enforcement Monitoring

• Closed investigations are randomly 

selected for follow-up to ensure continued 

compliance

Enforcement Reporting 

• Enforcement and Settlement Agreements 

• Posting of Adverse Actions & Appeal 

Decisions
Topics 

• NOP: Overview, Cross-Cutting Activities 

• Accreditation and International Activities 

• Compliance and Enforcement

• Standards 

USDA Agricultural Marketing Service | National Organic Program 33
Standards Division: Key Activities 

• Key Activities

– Develop new rules and coordinate clearance

– Develop and maintain Regulatory Priorities Agenda 

– Draft new and updated guidance and policy memos 

based on OIG feedback, certifier and community 

questions, and priority needs 

– Develop materials to support rollout of new 

standards, respond to letters and questions about 

standards 

– Maintain National List, including petition intake and 

response, and list management activities 

– Support the National Organic Standards Board

USDA Agricultural Marketing Service | National Organic Program 34
Standard Development 

• Rulemaking

• Organic Livestock and Poultry Practices

• Final rule published 

• Sunset 2016 Final Rule (published August 

2016)

• Removed egg white lysozyme, cyclohexylamine, diethylaminoethanol, 

octadecylamine, tetrasodium pyrophosphate from National List

• Sunset 2017 Proposed Rule

• Proposed removal of lignin sulfonate, furosemide, magnesium 

carbonate, Chia, dillweed oil, frozen galangal, inulin, frozen 

lemongrass, chipotle chile peppers, turkish bay leaves, and whey 

protein concentrate from National List

• Proposed rule is open for comment

USDA Agricultural Marketing Service | National Organic Program 35
Standards Development

• Guidance

– Classification of materials (published December 

2016)

• procedure used to classify materials as synthetic or nonsynthetic, and 

as agricultural or nonagricultural

– Materials for Organic Crop Production (published 

December 2016)

• natural and synthetic materials that are allowed for organic crop 

production

– Calculation of Percent Organic Ingredients, draft

• Calculate organic percentages of multi-ingredient ingredients used in 

organic processed products. 

• Determine the organic content of single-ingredient products and raw 

agricultural products

• Guidance is open for comment

USDA Agricultural Marketing Service | National Organic Program 36
Questions/Discussion 

Agricultural Marketing Service | National Organic Program 

February 2017

37
United States Dept. of Agriculture | Agricultural Marketing Service

Organic Foods Production Act of 1990 (OFPA)

O

F

P

A
FEB. 2012 2
U.S. Code

3

54 Titles

in all.
U.S. Code – Title 7 - Agriculture

4

115 chapters

in all.
U.S. Code – Ch. 94 – Organic Certification

5
United States Dept. of Agriculture | Agricultural Marketing Service

OFPA Timeline
• (1) to establish national standards governing the 

marketing of certain agricultural products as 

organically produced products;

• (2) to assure consumers that organically produced 

products meet a consistent standard; and

• (3) to facilitate interstate commerce in fresh and 

processed food that is organically produced.

OFPA 6501 - Purposes
• 21 terms

• Key terms –

• Agricultural product

• Handle/handler

• Livestock

• Organically produced

• Person

• Synthetic 

OFPA 6502 - Definitions
• Program for organic producers and handlers.

• Provides for State programs.

• Consulting with the NOSB.

• Certification by certifying agents.

OFPA 6503 – National organic production 

program
• Produced and handled without synthetic chemicals.

• No synthetic chemicals to crop land for three years 

prior to harvest of an organic crop.

• Produced according to an OSP agreed to by the 

producer/handler and certifying agent. 

OFPA 6504 – National standards for organic 

production
• (a) Domestic products

• (1) In general

• On or after October 1, 1993—

• (A) a person may sell or label an agricultural product as 

organically produced only if such product is produced and 

handled in accordance with this chapter; and

• (B) no person may affix a label to, or provide other market 

information concerning, an agricultural product if such label or 

information implies, directly or indirectly, that such product is 

produced and handled using organic methods, except in 

accordance with this chapter.

OFPA 6505 – Compliance requirements
(b) Imported products may be produced by equivalent 

program.

(c) Exemptions for processed food. Must be at least 

50% organic content. Secretary determines details.

(d) Small farmer exemption; persons who sell less than 

$5K annually in organic products.

OFPA 6505 – Compliance requirements
• Must be produced and handled on certified organic 

operations in accordance with this chapter.

• Organic plan required.

• Provides for appeal process.

• Provides for certification/ annual inspections.

• Periodic residue testing.

• Provides for enforcement by the Secretary.

• Public access to certification and lab documents.

• Authorizes reasonable fees to be collected.

• Other terms as required by the Secretary.

OFPA 6506 – General requirements
• Discretionary requirements:

• May certify all or part of an operation

• Boundaries and buffer zones

• Maintain separate records and make available to the 

Secretary.

• Segregate products and prevent commingling and 

contamination.

• Provide for exemptions for Federal or State emergency 

pest programs.

OFPA 6506 – General requirements
• Wild seafood may be certified as organic.

• State organic programs may contain addition 

requirements.

• Availability of fees for accreditation – fees credited 

to account of the program providing services under 

this chapter. Use shall not require appropriation. 

OFPA 6506 – General requirements
• States may apply to become a State organic program.

• May impose additional requirement if approved by the 

Secretary.

• NOP will review State programs at least every 5 years.

OFPA 6507 – State organic certification 

program
• Seeds and planting materials must comply.

• Soil amendments must not contain prohibited 

substances.

• May not use persistent, natural poisons.

• No plastic mulches unless removed at the end of the 

growing season.

• Must not use transplants treated with any synthetic 

or prohibited material.

OFPA 6508 – Prohibited crop production 

practices and materials
• Slaughter stock must be organically managed.

• Non-organic breeder stock may be sourced before 

last third of gestation.

• Feeding prohibitions (plastic, manure, urea)

• No growth promotors and hormones on livestock, 

including antibiotics and synthetic trace elements to 

stimulate growth or production. 

OFPA 6509 – Animal production practices 

and materials
• No subtherapeutic antibiotics.

• No routine use of parasiticides.

• No medications in the absence of illness (except 

vaccines).

• One year dairy transition.

• Livestock identification required for traceback to the 

farm.

• Records – medications and feeds (sources and use).

OFPA 6509 – Animal production practices 

and materials
• No synthetic ingredients, except from NL.

• No materials containing nitrates, heavy metals, or 

toxic residues.

• No sulfites (except for wine), nitrates, nitrites.

• No non-organic ag products except as specified.

• No packaging materials containing preservatives, 

fungicides or fumigants.

• Water in contact with product must meet SDWA.

• No contact or commingling

OFPA 6510 – Handling 
• Residue testing of organic products.

• Pre-harvest tissue testing.

• Inspection and removal of organic label.

• Intentional application of prohibited substances.

• Presence of prohibited substances above UREC.

OFPA 6511 – Additional guidelines
• Other practices are allowed unless prohibited or 

otherwise restricted, unless it is determined that 

such practice would be inconsistent with applicable 

organic certification program.

OFPA 6512 – Other production and 

handling practices
• Producers and handlers must have an organic plan.

• Crop plan must foster soil fertility by managing organic 

material through tillage, crop rotation, and manuring.

• Livestock operations may be combined with crops.

• Handling operations must have an OSP & be certified.

• Wild crops may be certified with approved OSP.

• OSP’s may not include any prohibited substance or 

practice.

OFPA 6513 – Organic plan
• States or private persons may be accredited under 

OFPA to be certifiers.

• Must apply to the Secretary and have sufficient 

expertise. 

• Period of accreditation is set at 5 years.

OFPA 6514 – Accreditation program
• Certifiers must be able to implement the program.

• Must have a sufficient number of inspectors.

• Certifiers must enter agreement with the Secretary.

• Confidentiality

• Avoid conflicts of interest.

• Provides for suspension of certifying agents.

• If suspended, Secretary or State Official will 

determine whether farming or handling operations 

may retain organic certification.

OFPA 6515 – Requirements of certifying 

agents
• Secretary shall consider a report concerning 

applicants for accreditation prepared by a a peer 

review panel.

• Secretary may establish a panel of NLT 3 persons 

with expertise in farming and handling to evaluate 

state organic programs or certifying agents. At least 

2 will not be USDA employees.

OFPA 6516 – Peer review of certifying 

agents
• National List of approved and prohibited substances.

• Itemized by specific use or application.

• Allowed synthetics and prohibited naturals. 

• NOP cannot add substances to list without a Board 

recommendation.

• Specific criteria for adding materials to the NL.

OFPA 6517 – National List
National Organic Standards Board

• 15-member advisory board appointed by the 

Secretary

• Review and recommend materials to be added to or 

deleted from the National List of Allowed and 

Prohibited Substances

• Advise on other standards or policies for 

implementation of OFPA.

OFPA 6518 – NOSB
National Organic Standards Board

• 4 own or operate an organic farm.

• 2 own or operate an organic handling operation.

• 1 owns or operates a retail establishment with 

significant trade in organic products.

• 3 experts in environmental protection and resource 

conservation.

• 3 represent public or consumer interest groups.

• 1 expert in toxicology, ecology, or biochemistry.

• 1 certifying agent.

OFPA 6518 – NOSB
• (1) the potential of such substances for detrimental chemical interactions with National Organic Standards Board

other materials used in organic farming systems;

• (2) the toxicity and mode of action of the substance and of its breakdown 

products or any contaminants, and their persistence and areas of 

concentration in the environment;

• (3) the probability of environmental contamination during manufacture, use, 

misuse or disposal of such substance;

• (4) the effect of the substance on human health;

• (5) the effects of the substance on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil 

organisms (including the salt index and solubility of the soil), crops and 

livestock;

• (6) the alternatives to using the substance in terms of practices or other 

available materials; and

• (7) its compatibility with a system of sustainable agriculture.

OFPA 6518 – National List criteria
• Section revised by 2014 Farm Bill

• Describes document retention and access by USDA.

• Provides specificity for confidentiality requirements.

• NOTE: with exception as provided by 6506(a)(9).

• Special investigative powers

• Administer oaths.

• Issue subpoenas.

• Compel attendance of witnesses.

OFPA 6519 – Recordkeeping, investigations, 

and enforcement
• Provides for a regulatory appeals process.

• Action adversely affects a person, or

• Action is inconsistent with the certification program.

• Provides for appeals beyond the Secretary to go to 

U.S. District court for which the person is located.

OFPA 6520 – Administrative appeal
• Directs Secretary to issue proposed rules 18 months 

after November 28, 1990.

• Provides for technical and financial assistance to 

States that implement an organic certification 

program.

OFPA 6521 – Administration
• This section of the law provides for “discretionary” 

funding for the NOP; up to $15M for 2014 to 2018. 

• Also provided for additional monies beyond 2009.

• This was part of the 2008 farm bill that gave NOP 

the big boost it needed to spin off its own program 

from under Transportation and Marketing Programs.

• Provided $5M in “no year” money from CCC for 

technical upgrades, specifically to the database.

OFPA 6522 – Authorization of 

appropriations
• Assists producers and handlers with cost of certification.

• Up to 75% of cost of certification.

• Not to exceed $750.

• Note: This is separate from the Agricultural Management 

Assistance cost share program offered to 16 states 

through NRCS.

OFPA 6523 – National organic certification 

cost-share program
• Added July 29, 2016

• Certified organic food does not have to be labeled as not 

being genetically engineered.

• Organic certification is sufficient to support claims of 

absence of bioengineering in the food or claims of “not 

bioengineered” or “non-GMO”, or similar claim.

OFPA 6524 – Labeling of organically 

produced food

United States Department of Agriculture

Agricultural Marketing Service

USDA Organic Regulations: 

Overview 

1
United States Department of Agriculture

Agricultural Marketing Service

NOP Definition of “organic”:

A production system, managed in 

accordance with the Act and USDA 

Regulations, to respond to sitespecific conditions by integrating 

cultural, biological, and mechanical 

practices that foster cycling of 

resources, promote ecological 

balance, and conserve biodiversity.

2
United States Department of Agriculture

Agricultural Marketing Service

• Definitions

– Commercially available

– Excipients

– Excluded methods

– Handler

– Labeling

– Livestock – (excludes aquatic animals)

– Prohibited substance

– Unavoidable residual environmental 

contamination

3
United States Department of Agriculture

Agricultural Marketing Service

• Applicability

– What has to be certified

– Exemptions and Exclusions

– Recordkeeping

– Allowed and prohibited substances, methods, and 

ingredients

4
United States Department of Agriculture

Agricultural Marketing Service

Banned in Organic Production 

and Handling

• Use of genetic engineering 

(GMO)

• Use of ionizing radiation

• Sewage sludge

5
United States Department of Agriculture

Agricultural Marketing Service

• Organic production and handling

– Maintain or improve natural resources (soil and 

water quality)

– Organic System Plan

– Soil fertility

– Seeds and planting stock

– Crop rotation

– Pest management practice standard

6
United States Department of Agriculture

Agricultural Marketing Service

Natural Resources

NOP 205.200

Practices must improve or 

maintain the natural 

resources of the 

farming operation, 

including soil and water 

quality.

7

NOP Regulations: Crop Production
United States Department of Agriculture

Agricultural Marketing Service

Organic Systems Plan

• Practices and procedures

• Substances to be used

• Monitoring practices to 

ensure plan works

• Recordkeeping system

• Preventing contact with 

prohibited substances

• Other info deemed 

necessary by certifier.

8

CERTIFICATION AND THE OSP
United States Department of Agriculture

Agricultural Marketing Service

NOP Regulations: Crop Production

• No prohibited substances on land/fields for 3 years

• Establish buffer zones

• Maintain or improve soil condition

• Minimize soil erosion

• Rotations, cover crops, and application of plant and 

animal material

• No raw manure applications within 120/90 days before 

harvest.

9
United States Department of Agriculture

Agricultural Marketing Service

Organic Seeds

NOP 205.204

• Organic seeds/planting stock 

required unless organic 

seeds/planting stock is not 

commercially available.

• If organic seeds not commercially 

available then untreated seeds 

may be used.

• Treated seeds are prohibited.

10

NOP Regulations: Crop Production
United States Department of Agriculture

Agricultural Marketing Service

Pest Management

NOP 205.206

Bio-intensive pest management plans. • Prevention first: – Crop rotations; – Resistant varieties; – Maintaining beneficial species habitat; – Sanitary cultural practices; • Approved materials used only when crop 

rotation, biological control, and cultural 

practices are insufficient to control pests.

11

NOP Regulations: Crop Production
United States Department of Agriculture

Agricultural Marketing Service

Wild Crop Harvest

• Sustainable harvest of defined area

• No prohibited substance exposure

• Protect the environment during harvest

12
United States Department of Agriculture

Agricultural Marketing Service

NOP Organic Livestock

• Managed Organically from 

last 3rd of gestation

– Poultry from second day 

of life.

– Dairy animals may be 

converted in 1 year

13

NOP Regulations: Livestock
United States Department of Agriculture

Agricultural Marketing Service • 100% Organic Feed – Synthetic vitamins and 

trace minerals are 

Allowed

• Prohibited Substances – No Synthetic Hormones 

or Growth Promoters

– No Antibiotics

• Animal Welfare – living 

conditions – Pasture requirement for 

ruminants

– Outdoor access

14

NOP Regulations: Livestock
United States Department of Agriculture

Agricultural Marketing Service

NOP Regulations: Handling HANDLING:

• Processing must be by certified operations

• Mechanical or biological methods for processing organic 

agricultural products

• “Organic” products: non-organic ingredients or processing 

aids must be on the National List

• Maintain organic integrity

• Preventive facility pest management

15
United States Department of Agriculture

Agricultural Marketing Service

NOP Organic Handlingcontinued

• Avoid contact with prohibited substances

• Segregate from conventional product

• Label according to NOP regulations.

NOP Regulations: 

16

Handling
United States Department of Agriculture Understanding Organic Agricultural Marketing Service

Labeling

•100% Organic

All ingredients & processing aids must 

be 100% certified organic.

•Organic 

95% - 100% certified organic 

ingredients.

•Made with Organic ...(list up to three 

ingredients or food groups)

At least 70% organic ingredients.

•Less Than 70% Organic Ingredients 

Claims are limited to ingredient 

statement.

17
United States Department of Agriculture

Agricultural Marketing Service

Subpart E - Certification

1. General requirements

2. Application

3. Review of application

4. Inspection

5. Certification

6. Denial of certification

7. Continuation of certification

39

CERTIFICATION AND THE OSP
United States Department of Agriculture

Agricultural Marketing Service

Accreditation of Certifying Agents 

7 CFR Subpart F 205.500-510

• The USDA Administrator of the Agricultural Marketing 

Service shall accredit a qualified applicant in the areas 

of crops, livestock, wild crops or handling or 

combination thereof to certify production or handling 

as a certified operation
United States Department of Agriculture

Agricultural Marketing Service

General Requirements for 

Accreditation

• Have sufficient expertise 

to fully comply with and 

implement the terms and 

conditions of the organic 

certification program 

established under the Act 

and regulations

• Education

• Experience

• Training

• Administration

• Regulations

• Inspection/auditing

• Crops/livestock/process

ing/handling/wild crops
United States Department of Agriculture

Agricultural Marketing Service

General Requirements 

– Internal Audits

Have an annual program review of its 

certification activities conducted by the 

certifying agent’s staff, an outside 

auditor, or a consultant who has 

expertise to conduct such reviews and 

implement measures to correct any 

noncompliances identified in the 

evaluation

• Internal Audits

– Conducting by internal 

personnel or outside auditor

– Evaluation of certification 

system and procedures

– Continuous Improvement

– Identify areas of strength and 

areas needing improvement

– Better to find issues during an 

internal audit then during an 

external audit.
United States Department of Agriculture

Agricultural Marketing Service

General Requirements – conflicts 

of interest

• Prevent conflicts of interest by:

Not certifying a production or handling operation if the 

certifying agent or a responsible connected party of such 

certifying agent has or has held a commercial interest in 

production or handling operation, including an immediate 

family interest or consulting within the 12 month period 

prior to the application of certification
United States Department of Agriculture

Agricultural Marketing Service

General Requirements – accepting 

all certification decisions

• One rule to rule them all

• All certifiers must comply 

with the NOP regulations

• Certifiers cannot require any 

additional requirements 

beyond the NOP regulations

NOP accredited certifiers 

must accept certification 

decisions made by other 

NOP accredited certifiers.

Especially important for 

processed products 

utilizing ingredients 

certified by other 

certifiers.
United States Department of Agriculture

Agricultural Marketing Service

Evidence of expertise – 205.504

• Policies and procedures for 

training, evaluating and 

supervising personnel

• Qualifications of staff

• Procedures used to evaluate 

applicants for certification

• Investigative procedures

• Residue testing procedures

• Procedures for 

handling violations

• Recordkeeping 

procedures

• Fees charged for 

certification

• Sample collection 

procedures
United States Department of Agriculture

Agricultural Marketing Service

Public information

• Procedures for providing to the public the following 

information:

– Organic certificates issued during the current and previous 3 

years

– List of all certified operations and products produced

– Results of laboratory analyses for residues of pesticides and 

other prohibited substances.
United States Department of Agriculture

Agricultural Marketing Service

Peer Review Panel

• Procedures for providing to the public the following 

information:

– Organic certificates issued during the current and previous 3 

years

– List of all certified operations and products produced

– Results of laboratory analyses for residues of pesticides and 

other prohibited substances.
United States Department of Agriculture

Agricultural Marketing Service

Annual Reporting & Recordkeeping

• Submit updates of information

• Lists of certified operations

• Document retention timeframes

• Renewal of accreditation every 5 years
United States Department of Agriculture

Agricultural Marketing Service

Subpart G – Administrative

• 205.600 evaluation criteria

• 205.601 – Crops – allowed synthetics

• 205.602 – Crops – prohibited naturals

• 205.603 – Livestock – allowed synthetics

• 205.604 – Livestock – prohibited naturals

• 205.605 – Handling – allowed non-agricultural 

substances (natural and synthetic)

• 205.606 – Handling – allowed agricultural 

(commerially unavailable in organic form)

28
United States Department of Agriculture

Agricultural Marketing Service

• 205.620-622 State organic programs

• 205.640-642 Fees

• 205.660-668 Compliance

• 205.670-672 Inspection and testing

• 205.680-681 Appeals

29
National Organic Standards Board 

Training: 

Federal Advisory Committee Act (FACA)

February 2017

1
Goal: Review Key Elements of FACA

• FACA Overview 

• Agency Responsibilities 

• Board Responsibilities

• NOP Authority in Setting Board Policy 

• Shared Success Factors 

2
Federal Advisory Committees 

• OFPA: Secretary has responsibility to establish the 

NOSB in accordance with the Federal Advisory 

Committee Act (FACA) 

• FACA Committees are established for the purpose of 

obtaining advice or recommendations on issues or 

policies within the scope of an agency official’s 

responsibilities 

• Like the NOSB, many FACA Boards are statutory.

• Federal advisory committees exist to advise and 

recommend, NOT to decide. 
FACA Committees Must Have.... 

• A charter with established mission and duties: 

The USDA renews the NOSB Charter every two years.

• Fair and balanced membership: The Secretary 

appoints NOSB members based on OFPA categories.

• A Designated Federal Official (DFO) for advisory 

committee and its subcommittees. FACA assigns a 

number of activities to the DFO. 

• Opportunity for reasonable participation by the 

public in advisory committee activities, subject to 

agency guidelines.

4
FACA Meeting Rules

• Open meetings with opportunity for public comment

• Any member of the public is permitted to file a written 

statement with advisory committee.

• Any member of the public may speak to or address 

advisory committee within appropriate guidelines.

• Feedback from previous CMO: “Only a few Boards have 

high comment rates, and of those, NOSB is 2nd highest.”

• Examples of public comment periods offered by others: 

– 2015 Dietary Guidelines Advisory Committee - 2 day 

meeting; 4 hours of oral comment. 

– USFS Committee: Forest Planning Rule 

Implementation. 1 day meeting; 1 hour of comment. 
FACA Meeting Rules 

• Reasonable time and accessible to the public; 

with sufficient space to accommodate 

committee, agency staff, and a reasonable 

number of the interested members of the public.

• Meetings must be announced 15 days in 

advance in Federal Register; Meeting minutes 

are required and are publicly available. 

6
FACA Representatives

• FACA members may be regular government 

employees, special government employees, and/or 

representatives: NOSB members are Representatives

• NOSB members are classified as representatives.

– Appointed based on ability to articulate and 

represent group’s interests 

– In representing others, speak in “We” not “I” 

statements 

– Are not expected to provide independent expert 

advice.

7
Subcommittees Versus Committees 

• Subcommittees are considered part of the FACA, BUT, 

FACA’s openness requirements do not apply. 

• This is because: 

• NOSB subcommittee proposals do not come directly 

to USDA – they come through the NOSB Committee. 

• The full committee deliberates on Subcommittee 

work. 

• This is why subcommittee calls are not currently open 

to the public. This is also why we call subcommittee 

products proposals rather than recommendations. 

8
Agency Responsibilities

• Comply with FACA 

• Issue administrative guidelines and management controls 

that apply to advisory committees

• Designate a Committee Management Officer (CMO) and 

Designate a Designated Federal Officer (DFO) for each 

advisory committee and its subcommittees

• Provide a written determination stating the reasons for 

closing any advisory committee meeting to the public

• Review, at least annually, the need to continue each 

existing advisory committee, consistent with the public 

interest and the purpose of each advisory committee
Agency Responsibilities

• Determine that ...staff, experts and consultants to 

advisory committees are justified and levels of agency 

support are adequate

• Develop procedures to assure that the committee’s 

recommendations will not be inappropriately influenced 

by the appointing authority or by any special interest, but 

will instead be the result of the committee's independent 

judgment

• Assure that the interests and affiliations of advisory 

committee members are reviewed for conformance with 

applicable conflict of interest statutes, regulations issued 

by Office of Government Ethics including any supplemental 

agency requirements, and other Federal ethics rules
NOP Responsibilities

• NOP’s Designated Federal Officer (DFO):

– Calls, attends, and adjourns committee meetings 

– Develops and approves agendas

– Maintains required records and budgets

– Ensures efficient operations and adherence to 

FACA and other laws 

– Develops committee reports for the Committee 

Management Officer: We must submit an annual 

report on Board activities, meetings, and 

expenses. 
FACA: Board Responsibilities 

• How should agencies consider the roles of 

advisory committee members and staff?

• FACA does not assign any specific responsibilities to 

members of advisory committees and staff (other than 

DFO), although both perform critical roles

• Agency heads, Committee Management Officers 

(CMOs), and Designated Federal Officers (DFOs) 

should consider the distinctions between these roles 

and how they relate to each other in developing 

agency guidelines implementing FACA 
NOP Authority in Setting Board Policy 

• Agency Guidelines for implementing FACA 

should reflect: 

– Clear operating procedures should provide for the 

conduct of advisory committee meetings and other 

activities, and specify the relationship among the 

advisory committee members, the DFO, and staff;

– In addition to complying with the Act, advisory 

committee members ....may be required to adhere to 

additional agency operating policies; and

– Other agency-specific statutes and regulations may 

affect the agency's advisory committees directly or 

indirectly. 

13
FACA and OFPA together

• OFPA doesn’t direct the NOSB to decide. 

• OFPA asks NOSB to: 

– Assist in development of Standards

– Provide recommendations 

– Evaluate substances

– Develop proposed National List and proposed 

amendments to the List for submission to the 

Secretary

• Secretary (authority delegated to AMS) retains 

decision-making and rulemaking authority 
Criteria for Success Under FACA.... 

• Enhance accountability to public

• Control the undue influence of special 

interests by balancing committee 

membership

• Ensure that public access to committee 

deliberations is maximized.

• Monitor and reduce costs

• Eliminate unproductive and/or unnecessary 

committees

• Provide for an annual report of committee 

activities and accomplishments to Congress

15
NOP and NOSB Success Factors

• NOP’s success is measured in part by its success in 

managing the NOSB: 

– Are recommendations within the Committee’s 

scope? (OFPA statute and agency responsibilities)

– Are Board and program resources being used 

effectively and efficiently? 

– Is the NOP asking for advice that it can then act 

upon? (It wastes time and resources for the Board 

to work on items that the NOP cannot implement.)

– Are appropriate management structures and 

processes in place and functioning? 
Questions/Discussion 

Agricultural Marketing Service | National Organic Program 

February 2017

17
National List Petition Process

1

Lisa M. Brines, Ph.D.

Agricultural Marketing Service | National Organic Program 

February 2017

NOSB Training
Multiple inputs for NOSB Recommendations

NOSB 

Recommendation

Petition

Technical 

Report

Subcommittee

Proposal

Public 

Comment

USDA Agricultural Marketing Service | National Organic Program 2
Materials Review

NOSB has a Well-Developed Evaluation

Process and Structure for Materials Review

• Evaluation Forms with Criteria linked to Organic 

Foods Production Act and USDA organic 

regulations.

• Boundaries for communicating with petitioners.

• Projected Timeline for review steps.

USDA Agricultural Marketing Service | National Organic Program 3
Petition Process

The Organic Foods Production Act:

Sec. 2119. [7 U.S.C. 6518] National 

Organic Standards Board.

(n) Petitions.—The Board shall establish 

procedures under which persons may 

petition the Board for the purpose of 

evaluating substances for inclusion on the 

National List.

USDA Agricultural Marketing Service | National Organic Program 4
Petition Process

USDA Organic Regulations, 7 CFR Part 205

§205.607 Amending the National List.

(a) Any person may petition the National Organic 

Standards Board for the purpose of having a 

substance evaluated by the Board for 

recommendation to the Secretary for inclusion on 

or deletion from the National List in accordance 

with the Act. 

(b) A person petitioning for amendment of the 

National List should request a copy of the petition 

procedures from the USDA at the address in 

§205.607(c). 

USDA Agricultural Marketing Service | National Organic Program 5
Updated National List Petition Process

• Changes to the National List may be requested 

using petitions

• Any person may submit a petition

• Process updated on March 11, 2016

• New Program Handbook document, NOP 3011

• Implemented two NOSB recommendations

USDA Agricultural Marketing Service | National Organic Program 6
Updated National List Petition Process

• Eliminates provision for submission of 

Confidential Business Information (CBI)

• Clarified procedures for certain types of 

petitions, such as annotation (restrictions)

• Answers common questions about the 

petition process to clarify the role of the NOP, 

the role of the NOSB, and the criteria used to 

evaluate petitions

USDA Agricultural Marketing Service | National Organic Program 7
Petition Process: Petition Guidelines

• Guidelines explain what information 

must be included in a petition

• No specific template or form is required

• No fee or cost to petition

• Petitions may not contain confidential 

business information (CBI). CBI is not 

available to NOSB or public.

USDA Agricultural Marketing Service | National Organic Program 8
Petition Example

• Petitioned Material: Sulfur

• Petitioner: Georgia Gulf Sulfur Corporation

• Petitioned Use: Livestock use as a pesticide 

(repellent for mites, fleas, and ticks)

• Status: Under review by National Organic 

Standards Board (NOSB); Technical Report in 

Development

USDA Agricultural Marketing Service | National Organic Program 9
NOP’s Internal Process

• NOP confirms receipt of petition

• NOP reviews incoming petition for 

eligibility and sufficiency (generally 

within 30 days of submission)

• NOP is the primary point of contact for 

any correspondence between NOSB and 

petitioner

USDA Agricultural Marketing Service | National Organic Program 10
NOP’s Internal Process

NOP’s goal is to make sure that petitions are eligible 

and complete when they are distributed to the 

Subcommittee, so that revisions and supplementary 

petition information are infrequent

Two NOP checklists:

• OFPA Checklist, NOP 3005-1

• Petition Checklist, NOP 3005-2

Checklists are completed by NOP staff and 

provided to the NOSB Subcommittee, but are 

not posted for the public

USDA Agricultural Marketing Service | National Organic Program 11
NOP’s Internal Process

• OFPA Checklist, NOP 3005-1

–Used to verify eligibility of the 

substance for addition to the National 

List

– Substances that are not eligible are 

not forwarded to the NOSB for review

USDA Agricultural Marketing Service | National Organic Program 12
Ineligible Petitions

• Formulated (brand name) products

• Food additive without FDA approval

• Pesticide without EPA tolerance or tolerance 

exemption

• Requests to add substances already allowed

• Synthetic NPK fertilizers

• Materials otherwise prohibited by the USDA 

organic regulations (e.g., sewage sludge, 

GMOs, etc.)

• Previously petitioned/rejected materials (if 

no new information is provided)

USDA Agricultural Marketing Service | National Organic Program 13
NOP’s Internal Review

Eligibility review of previously petitioned/rejected 

materials

– NOP reviews previous petition and technical report(s) for the 

substance

– NOP identifies why the substance was prohibited

– NOP reviews new petition for any information that was not submitted 

in an earlier petition or provided in the technical report

– No new information

• Petitioner is notified that substance was previously reviewed and 

rejected and that no new information was provided

– New information

• Petition proceeds to NOSB review. NOP does not determine 

whether the new information would be likely to warrant a change 

in decision

**Important that NOSB proposals to reject petitions also contain 

sufficient justification**

USDA Agricultural Marketing Service | National Organic Program 14
NOP’s Internal Process

• Petition Checklist, NOP 3005-2

– Used to verify that the petition meets the 

submission guidelines

– NOP does not fact check all of the data 

provided

– NOP may identify areas where more 

information or references are needed for 

completeness

– NOP’s “sufficiency” determination does not

mean NOP believes the substance should be 

added to the National List; only that it meets 

the eligibility requirements for NOSB review

USDA Agricultural Marketing Service | National Organic Program 15
Petition Process

• Examples of incomplete petitions:

– No description of alternatives

– Labels not submitted

– No reference list provided

– Inadequate description of previous 

reviews (e.g., NOSB reviews)

– Inadequate description of physical 

properties and chemical mode of action

– Contains confidential business 

information (CBI)

USDA Agricultural Marketing Service | National Organic Program 16
NOP’s Internal Review

• “...acceptance of the petition for NOSB 

review is an administrative matter and 

does not reflect a decision by NOP on the 

substantive merits of the petition.”

• “...the NOSB, during its evaluation of the 

petitioned substance, may have additional 

requests for information. A notice will be 

sent to you should the NOSB request 

additional information.”

USDA Agricultural Marketing Service | National Organic Program 17
NOP’s Process

• Updated Petition Information

– Petitioner may submit updated 

(unsolicited) information after 

petition has been sent to NOSB

– Petitioner may respond to additional 

information requested by NOSB

• Updates are posted alongside petition 

on NOP website

USDA Agricultural Marketing Service | National Organic Program 18
NOSB Subcommittee Process

Petition – NOSB subcommittee review

• Should be completed within 60 days of 

receipt of petition

The NOSB subcommittee may request:

a) Additional information from petitioner

b) Technical report

USDA Agricultural Marketing Service | National Organic Program 19

Adapted from NOSB Policy & Procedures Manual
Technical Reports

• Completed by third-party contractors

• Technical report templates include evaluation 

questions derived from OFPA criteria

• Minimum of 4 months for development

• Reports are posted on NOP website after 

acceptance by NOSB Subcommittee

USDA Agricultural Marketing Service | National Organic Program 20
NOSB Process: TR Requests

• Requests for technical reports (TRs) should 

be submitted within 60 days of receipt of 

petition

• TRs are always optional, but may be 

requested at the discretion of the 

Subcommittee

• Any additional information requested 

(beyond the scope of a standard technical 

report), must be aligned with the OFPA 

criteria

• If particular areas of focus are needed, 

please provide the details in the request.

USDA Agricultural Marketing Service | National Organic Program 21
NOSB Process: TR Requests

• For petitions to add new substances to the 

National List, we do not recommend limiting the 

scope of the technical report

• Limited scope / supplemental TRs may be 

appropriate in the following scenarios:

– Crop or livestock petitions where classification 

is unclear

– Petitions to amend an existing annotation

– Petitions to remove an existing substance

– Sunset substances

USDA Agricultural Marketing Service | National Organic Program 22
Technical Report Content

• Technical reports do not currently 

include:

– Proprietary information

– Economic impact information

• NOP accepts quality, accuracy and 

completeness of technical reports

USDA Agricultural Marketing Service | National Organic Program 23
Technical Reviews, cont.

• NOP reviews all TRs before they are distributed to 

the Subcommittee to ensure they meet the 

requirements of the contract

• NOP will ensure that TRs are sufficient and complete 

when they are distributed to the Subcommittee 

• Occasionally, NOP will request that a subject matter 

expert from the Agricultural Research Service review 

a draft copy of the report. When this occurs, it will 

be noted when NOP distributes the report to the 

Subcommittee

USDA Agricultural Marketing Service | National Organic Program 24
Petition Process: Substance Evaluation Criteria

1. The potential of such substance for 

detrimental chemical interactions with other 

materials used in organic farming systems;

2. The toxicity and mode of action of the 

substance and of its breakdown products of 

any contaminants, and their persistence and 

areas of concentration in the environment;

3. The probability of environmental 

contamination during manufacture, use, 

misuse, or disposal of such substance;

4. The effect of the substance on human health;

USDA Agricultural Marketing Service | National Organic Program 25

OFPA, Sec. 2119(m)
5. The effect of the substance on biological 

and chemical interactions in the 

agroecosystem, including the 

physiological effects of the substance on 

soil organisms (including the salt index 

and solubility of the soil), crops and 

livestock;

6. The alternatives to using the substance in 

terms of practices or other available 

materials; and

7. Its compatibility with a system of 

sustainable agriculture. 

USDA Agricultural Marketing Service | National Organic Program 26

Petition Process: Substance Evaluation Criteria

OFPA, Sec. 2119(m)
Technical Advisory Panels (TAPs)

• OFPA: The NOSB shall convene technical advisory 

panels to provide scientific evaluation of materials 

considered for the National List. 

• The NOSB has not convened independent Technical 

Advisory Panels since 2005. Currently the NOSB is 

relying on information within the Technical Reports 

provided by the NOP and public comment to make 

their final recommendations.

• TAPs previously included recommendations. 

Technical reports do not recommend actions to the 

NOSB.

USDA Agricultural Marketing Service | National Organic Program 27
Petition Process: 205.606 Evaluation Criteria

The NOSB shall determine whether agricultural substances 

petitioned for Section 205.606 are potentially commercially 

unavailable.

The NOSB will consider:

• Why the non-organic form of the substance is necessary 

for use in organic handling;

• The current and historical industry 

information/research/evidence that explains how or why 

the substance cannot be obtained organically in the 

appropriate form, quality, or quantity to fulfill an essential 

function in a system of organic handling.

USDA Agricultural Marketing Service | National Organic Program 28

Petition guidelines, NOP 3011
Industry information includes, but is not 

limited to the following:

1. Regions of production, including factors such as 

climate and number of regions;

2. Number of suppliers and amount produced;

3. Current and historical supplies related to weather 

events such as hurricanes, floods, and droughts 

that may temporarily halt production or destroy 

crops or supplies;

USDA Agricultural Marketing Service | National Organic Program 29

Petition guidelines, NOP 3011

Petition Process: 205.606 Evaluation Criteria
Industry information includes, but is not 

limited to the following:

4. Trade related issues such as evidence of 

hoarding, war, trade barriers or civil unrest 

that may temporarily restrict supplies; and

5. Other issues which may present a challenge to 

a consistent supply.

USDA Agricultural Marketing Service | National Organic Program 30

Petition guidelines, NOP 3011

Petition Process: 205.606 Evaluation Criteria
NOSB Process – Petition Templates

• The NOSB templates are a tool to 

facilitate and document evaluation of 

the petitioned substance against the 

OFPA criteria

• Previous format used checklists; 

checklists are not used in current 

procedures

USDA Agricultural Marketing Service | National Organic Program 31
NOSB Review - Documentation

• In general, suggest limiting your answers to 

address the uses that are within the scope 

of the petition (although there may be 

exceptions, such as effects from misuse)

• Does recommendation demonstrate that 

NOSB met its obligation under OFPA to 

consider the criteria (e.g., effect of the 

substance on human health?)

• Comments should be used to document 

the review and to provide clarity for 

stakeholders

USDA Agricultural Marketing Service | National Organic Program 32
• For substances that have a broad 

spectrum of utility, the NOP 

recommends that, to the extent 

possible, the NOSB review materials 

with a lens limited to the manner and 

amount that the substance would be 

used in organic production and handling

USDA Agricultural Marketing Service | National Organic Program 33
• Questions?

USDA Agricultural Marketing Service | National Organic Program 34
Sunset Process

1

Lisa M. Brines, Ph.D.

Agricultural Marketing Service | National Organic Program 

February 2017

NOSB Training
Sunset Provision of OFPA

• No exemption or prohibition contained 

in the National List shall be valid unless 

the NOSB has reviewed such exemption 

or prohibition as provided in this section 

within 5 years of such exemption or 

prohibition being adopted or reviewed 

and the Secretary has renewed such 

exemption or prohibition

USDA Agricultural Marketing Service | National Organic Program 2

OFPA, Section 2118(e)
Sunset Dates

• Apply to National List substances

• Sunset dates are published in Program 

Handbook, NOP 5611

• 5 years is calculated from effective date 

of final rule or renewal

• For efficiency, sunset reviews are grouped 

by calendar year

USDA Agricultural Marketing Service | National Organic Program 3
Sunset Process

• Thorough and transparent review 

process for all substances - provides 

two public comment opportunities 

before the NOSB completes its review of 

each substance. 

• Ensures that any change to the National 

List (petitioned or sunset) is supported 

by a 2/3 majority of the NOSB.

• Streamlines the administration of the 

National List by simplifying rulemaking. 

USDA Agricultural Marketing Service | National Organic Program 4
What is the process?

• The Sunset Process is comprised of

two components: 

(1) The NOSB review (Steps 1-6) and 

(2) USDA action (Steps 7-8) on substances 

within 5 years of their addition to or renewal 

on the National List. 

• Key documents used for the review:

(1) Sunset List

(2) Preliminary Review

(3) NOSB Sunset Review

USDA Agricultural Marketing Service | National Organic Program 5
Process Mechanics

• Step 1 – Meeting announcement in Federal 

Register inviting comment on Sunset List 

(background may include requests for 

specific info from Subcommittees)

• Step 2 – Written public comments 

submitted and analyzed by Subcommittees

• Step 3 (Mtg #1) – Subcommittees 

summarize background and public 

comment & receive oral comment

USDA Agricultural Marketing Service | National Organic Program 6
Process Mechanics Cont’d

• Step 4 – Subcommittees analyze written 

and oral comments from Mtg #1 and 

prepare Preliminary Review. 

– Meeting announcement inviting 

comment on Preliminary Review

published in Federal Register

• Step 5 – Written public comments 

submitted and analyzed by 

Subcommittees

USDA Agricultural Marketing Service | National Organic Program 7
Process Mechanics Cont’d

• Step 6 (Mtg #2) – Subcommittees 

present Preliminary Review, receive 

oral comment, and discuss with the full 

Board.

– Motions for removal from the 

Preliminary Review are voted on by 

the full Board.

– After Mtg #2, NOSB completes Sunset 

Review. 

USDA Agricultural Marketing Service | National Organic Program 8
Process Mechanics Cont’d

• Step 7 – AMS reviews NOSB Sunset 

Review and considers rulemaking action 

for any recommended removals

• Step 8 – AMS issues Federal Register 

Notice announcing renewal of 

applicable substances 

USDA Agricultural Marketing Service | National Organic Program 9
Sunset 2019

July 2016

• Subcommittees submitted Technical Reports requests

Spring 2017 Meeting

• Sunset 2019 Summaries

• Public comment

Fall 2017 Meeting

• Sunset 2019 Reviews

• Public comment

• Decisions to remove made here

Before Sunset Dates in 2019 (October 30)

• AMS renewal and removals, as applicable.

USDA Agricultural Marketing Service | National Organic Program 10
Review New Documents

• Sunset list template

• Preliminary review template

• NOSB review template

USDA Agricultural Marketing Service | National Organic Program 11
New Sunset Recommendation

• In Fall 2016, NOSB passed 

recommendation on Sunset Review -

Efficient Workload Organization

• Objective to impartially and efficiently 

redistribute material reviews across 

several years

• Previously, most National List materials 

would sunset in the same year (every 5 

years from 2002)

USDA Agricultural Marketing Service | National Organic Program 12
• Questions?

USDA Agricultural Marketing Service | National Organic Program 13
Rulemaking

1

Shannon Nally Yanessa

Agricultural Marketing Service | National Organic Program 

February 2017

NOSB Training
Objectives 

• What happens when NOP receives an 

NOSB recommendation for rulemaking?

• How do we get from recommendation 

to a proposed or final rule?

USDA Agricultural Marketing Service | National Organic Program 2
Framework

Administrative Procedures Act

• Fosters transparency and public participation 

in the rulemaking process.

Basic requirements:

– Publish a proposed rule in the Federal Register.

– Invite and consider public comments.

– Issue final rule at least 30 days before effective 

date. 

USDA Agricultural Marketing Service | National Organic Program 3
Rulemaking oversight

• Office of Information and Regulatory Affairs 

(OIRA) in the Office of Management and 

Budget (OMB)

– Operates as an “information aggregator” 

across government

– Facilitates interagency coordination & 

communication

– Considers costs and benefits of regulations

– Ensures public engagement in process

– Ensures compliance with relevant statutes 

• Reginfo.gov dashboard

USDA Agricultural Marketing Service | National Organic Program 4
How does NOP initiate a rulemaking? 

• Submit a regulatory workplan

– Summarizes objectives, possible 

alternatives, and effects of action to 

policy officials (non-technical)

– Provides information needed for 

“designation” of significance 

• Priority rulemaking actions appear on the 

Unified Agenda

– Communicates to OMB and public 

about agencies regulatory plan

USDA Agricultural Marketing Service | National Organic Program 5
Significance designation

• OMB reviews rules that may: 

– Have an annual effect on the economy of 

over $100 million or more, or adversely 

affect the economy, a sector of the 

economy, jobs, or competition;

– Create serious inconsistency or interferes 

with an action of another agency;

– Materially alter the budgetary impact of 

existing programs; or

– Raise novel legal or policy issues.

USDA Agricultural Marketing Service | National Organic Program 6
Significant vs Non-significant

What does this distinction mean in practice?

• Significant rules require additional analyses: 

– Regulatory Impact Analysis (cost-benefit) – E.O. 12866 & 

13563

– Regulatory Flexibility Act 

– Paperwork Reduction Act

– Consultation & Coordination with Indian Tribal 

Governments

– Civil Rights Impact Analysis

USDA Agricultural Marketing Service | National Organic Program 7
How does NOP draft a rule?

• Review all NOSB recommendations; technical 

information (e.g., TRs, petitions), overlapping 

regulations. 

• Review and analyze public comments (final rule).

• Draft overview of the amendment(s), including 

justification for action and info on implementation; 

• Draft amendatory instructions for Federal Register; 

• Conduct necessary supplementary analyses.

• Facilitate NOP approval; engage other Divisions as 

needed. 

USDA Agricultural Marketing Service | National Organic Program 8
How can public comments 

affect the final rule?

• The notice-and-comment process enables anyone to 

submit a comment on any part of a proposed rule. 

• An agency is not permitted to base its final rule on the 

number of comments in support of the rule over those in 

opposition to it. 

• The agency must base its reasoning and conclusions on the 

rulemaking record, consisting of the comments, scientific 

data, expert opinions, and facts accumulated during the 

pre-rule and proposed rule stages.

• If the rulemaking record contains persuasive new data or 

sound policy arguments, the agency may decide to 

terminate the rulemaking. 

• Or, the agency may decide to continue the rulemaking but 

change aspects of the rule to reflect these new issues. 

USDA Agricultural Marketing Service | National Organic Program 9
Clearance - review pathway

– Office of General Counsel & USDA General Counsel

– NOP Deputy Administrator

– AMS Administrator

– Office of Budget and Program Analysis

– Office of Risk Assessment and Cost Benefit Analysis

– Assistant Secretary, Civil Rights

– Office of Chief Economist

– Office of Chief of Information

– Office of Tribal Relations

– Undersecretary 

– Secretary

– OMB – includes interagency review. 

• 90-day review; can be extended. 

– (Congressional Review Act)

USDA Agricultural Marketing Service | National Organic Program 10

Red = needed 

for significant 

rules 
Why does rulemaking take so long?

• Review of NOSB recommendation

• Draft Regulatory Workplan for OMB Designation

• Draft Proposed Rule 

• Clearance & Federal Register Publication

• Comment Period

• Comment Analysis

• Workplan Addendum for OMB Designation

• Revise Required Analyses

• Draft Final Rule

• Clearance & Federal Register Publication

• Effective Date of Final Rule 

USDA Agricultural Marketing Service | National Organic Program 11

Proposed 

Rule 

Stage

Final Rule 

Stage
Resources

• A Guide to the Rulemaking Process

– Office of Federal Register

• The Office of Information and 

Regulatory Affairs: Myths and Realities

– Commentary By Cass R. Sunstein

• The Regulatory Plan and Unified Agenda

– Office of Management & Budget

USDA Agricultural Marketing Service | National Organic Program 12
Best Practices:

Proposals & Recommendations

Jessica Walden

Agricultural Marketing Service | National Organic Program 

February 2017

1

NOSB Training
Overview

• Review overall process and templates 

• Example of a non-materials proposal

• Critical pieces of proposals & 

recommendations

USDA Agricultural Marketing Service | National Organic Program 2
NOSB Process

USDA Agricultural Marketing Service | National Organic Program 3

SC work

Discussion 

Document

posted

Proposal

posted

NOSB 

Meeting 

NOSB 

Meeting 

Final 

Recommendation

Public

comment

Substantive 

Changes?
Proposals

• Proposals

– Come from Subcommittees

– Propose an action, include a SC vote 

– Examples: 

• Motion to List, Remove, or Change a 

substance 

• Motion that calls for policy 

clarification or guidance

• Motion to change the regulation 

elsewhere

USDA Agricultural Marketing Service | National Organic Program 4
Discussion document

• Provided by Subcommittee

–Used to collect information

– Posted for comment

• No vote taken at first meeting 

– Verbal update, discuss comments

• Returns to subcommittee for further 

development

• May be turned into a Proposal at next 

meeting

USDA Agricultural Marketing Service | National Organic Program 5
Recommendation

• Product of full board

• SC proposal is voted on at meeting

– Final product is considered the 

recommendation to NOP

• Cover sheet is added to the SC 

proposal to summarize final action

– If substantive changes are considered 

during a meeting, must get sent back 

to SC for revision and re-posting 

USDA Agricultural Marketing Service | National Organic Program 6
Other types of documents

• Reports or Updates 

– Subcommittee does not expect public 

comment, but wants to provide 

update to public

–No votes or action expected by NOP 

in response

USDA Agricultural Marketing Service | National Organic Program 7
Forms used 

• Materials Review Template for new 

petitions

– Crops and livestock version

– Handling version

• Other proposals - narrative

• Sunset templates 

– Initial Meeting 1 Summary

– Meeting 2 Subcommittee Prelim Review

– NOSB Final Sunset Review

USDA Agricultural Marketing Service | National Organic Program 8
Example of narrative format 

recommendation

Calculation of Organic Percentage in multiIngredient products, April 2013

Biodegradable Biobased Mulch, October 

2012

USDA Agricultural Marketing Service | National Organic Program 9
USDA Agricultural Marketing Service | National Organic Program 10
USDA Agricultural Marketing Service | National Organic Program 11
What are the critical pieces?

• Assessment of Existing Rule

– Did you check if other parts of the regulations 

may be impacted by your proposed action?

• E.g., sulfites in fortified wines, colors 

– If other parts are impacted, what is your 

advice?

• Accuracy

– Did you use the correct citations to OFPA and 

the USDA organic regulations?

• E.g., Tetracycline

USDA Agricultural Marketing Service | National Organic Program 12
What are the critical pieces?

• Clear Use of Technical Information

–Did you ensure that accurate citations for 

any technical information is included?

–Did you clearly articulate why the technical 

information is relevant and supports any 

justification?

• E.g., Carrageenan

USDA Agricultural Marketing Service | National Organic Program 13
What are the critical pieces?

• Clear Explanation of “Limits”

– If there is some quantitative limit proposed, 

did you articulate the basis for the limit?

• E.g., Methionine

• E.g., Stocking Density

USDA Agricultural Marketing Service | National Organic Program 14
What are the critical pieces?

• Use of Criteria

–Did you clearly explain your evaluation of 

the OFPA criteria and how it connects to 

your proposal?

• E.g., Why a natural material is not 

effective

– For 606 materials, did you discuss evidence 

of commercial availability? 

• E.g., hops

USDA Agricultural Marketing Service | National Organic Program 15
What are the critical pieces?

• Responsive

–Did you address the petitioner’s request? 

–Did you explain why you chose an 

alternative to or rejected the petitioned 

use?

• E.g., pet food amino acids

USDA Agricultural Marketing Service | National Organic Program 16
What are the critical pieces?

• Impacts on Organic Market

– To the extent that data or public comment 

is available, did you summarize information 

on expected impacts on...?

• Organic producers and handlers

• Organic consumers

• Certifying agents

USDA Agricultural Marketing Service | National Organic Program 17
Best Practices:

Evaluating Technical Reports

and Petitions, 

Developing Materials Proposals

Jessica Walden

Agricultural Marketing Service | National Organic Program 

February 2017

18

NOSB Training
Overview

• Identifying key information

– In petition

– In Technical Review

• Filling out the Materials Review 

Template

• Providing a summary narrative

USDA Agricultural Marketing Service | National Organic Program 19
Finding the Key Information

• You have just received an email 

with a large TR linked, and 

request for review 

USDA Agricultural Marketing Service | National Organic Program 20

Where to start?

• Identity

• Classification 

• What is it used 

for
Finding the Key Information

1. Identity of the Substance

- Is it obvious?

- Are there various forms?

- What was the petitioned form?

Example: formic acid

USDA Agricultural Marketing Service | National Organic Program 21
Finding the Key Information

• Identity 

– Is there one CAS number?

– Are there variations in form?

– Are there discrepancies between 

petitioned name and TR name?

USDA Agricultural Marketing Service | National Organic Program 22
Example of Identity Problem

• Petition was for “cellulose fibers” 

– For use in hot dog casings, also anticaking 

and filtering

• TR says: Chemical name = Cellulose, ß-1-4-Dglucan

– Other names include: 

• powdered cellulose; alpha-cellulose, flour 

cellulose; cellulose fibers. 

• Microcrystalline cellulose, MCC, (derived 

from cellulose) is also called cellulose gel.

• Cellulose casing, regenerated cellulose

USDA Agricultural Marketing Service | National Organic Program 23
Example of Identity problem

From TAP

• Cellulose

– CAS Number: 9004-34-6- alpha cellulose

• Other Codes:

INS numbers:

• 460 cellulose

• 460(i) microcrystalline cellulose

• 460(ii) powdered cellulose 

USDA Agricultural Marketing Service | National Organic Program 24
Example of Identity problem

• Best to identify the exact identity in final 

recommendation: 

– CAS number, INS number or other

–Will help in future reviews

USDA Agricultural Marketing Service | National Organic Program 25
Finding the Key Information

2. How should the substance be classified?

- Synthetic

- Nonsynthetic

- Agricultural

• Find this in the TR

• Does the petition also support this finding?

– If not, explain reasoning for a different 

determination

– Cite support for decision on Petition Review

Template

– Use Decision Tree 

– Classification of Materials Guidance

USDA Agricultural Marketing Service | National Organic Program 26
Finding the Key Information

3. What is the petitioned use?

- Is it clear from petition?

- Are there other uses mentioned in 

TR?

- Review Example: formic acid 

USDA Agricultural Marketing Service | National Organic Program 27
Read the Documents !

• Once oriented – read carefully the entire 

TR

• Revisit petition for comparison

– Petition Justification statement- does 

it seem valid?

• Then go through Review Template and 

answer questions.

• Discuss: does anyone have a different 

way to approach this?

USDA Agricultural Marketing Service | National Organic Program 28
Materials Review Template

• Provide reasoning

–Overall use is to balance overall 

evaluation, one factor might offset 

another

–No one criterion is determining

• Sometimes there is no answer, can 

indicate that information is lacking

USDA Agricultural Marketing Service | National Organic Program 29
Review Exercise - break into 2 groups 

• Category 1 – Classification and Category 

3 – Alternatives / Compatibility

• Category 2 – Adverse Impacts

USDA Agricultural Marketing Service | National Organic Program 30
Summary 

• Once template is complete, fill out 

Summaries on page 1

• Summary of Proposed Action

– Plainly describe what the proposed 

action is 

–Give brief justification for action, cite 

criteria met or not met

USDA Agricultural Marketing Service | National Organic Program 31
Questions? 

USDA Agricultural Marketing Service | National Organic Program 32
Best Practices: 

Comment Evaluation

33

Jessica Walden

Agricultural Marketing Service | National Organic Program 

February 2017

NOSB Training
Role of Public Comment

• Enables stakeholder feedback and 

participation 

• Provides input on current needs and uses

• Provides input on public concerns

• Improves the final NOSB recommendation

• Helps support the final NOP action

USDA Agricultural Marketing Service | National Organic Program 34
Challenges

• Large number of comments on some 

topics

• Limited time to review

• Not always specific or helpful

• Useful to have a system for review

– Start with a table

• Count numbers

• Summarize significant ideas

USDA Agricultural Marketing Service | National Organic Program 35
Weighing the comments

• NOSB should treat comments similarly as USDA 

does in rulemaking

– It is not a ballot initiative or an up-or-down vote 

– Total numbers for or against are not 

determinative alone

– NOSB recommendations should have 

justification based on comments, scientific data, 

expert opinions, and facts accumulated during 

the NOSB process.

– If the comments contains persuasive new data 

or sound policy arguments, the SC could defer a 

final recommendation, or re-propose with 

changes.

USDA Agricultural Marketing Service | National Organic Program 36
Examples 

Total comments: 25 - Bulk Handling Draft Guidance 

(Internal NOP review) 

USDA Agricultural Marketing Service | National Organic Program 37

Suggested changes Likes other

Certifiers Assoc. – 43 

signers

- Transporters optionally may be certified, thinks “handle” 

does not include transport

- provide definition of broker: does not physically handle? 

- Sealed containers – should mean tamper proof,& 

impermeable 

Supports in 

general

Supported by 

(mkt coop)

XYZ certifier handlers, not always reqd to be certified.

-Certifiers may not be able to inspect railroad cars and trucks

-have not been requiring hay brokers to be certified

organic farmer, MN -Undue burden on smaller growers using custom haulers

-will be a lack of transporters if all have to be certified

Also filed as 

assoc, 144 

members
Examples – NOSB meeting Oct 2012

Crops Subcommittee Presentation

Total in favor of adding Biodegradable Mulch Film: 163

– Farmers: 38

– Consumers: 114

– Organizations: 11 

(Including, among others: BPI; Beyond Pesticides; CCOF; Driscoll’s; NOFA; NatureWorks; Novamont; OTA; 

Oregon Tilth; Protema; USDA BioPreferred Program)

Total opposed to listing Biodegradable Mulch Film: 4

– Farmers: 0

– Consumers: 1

– Organizations: 3

(CFS; Organically Grown Company; PCO)

Total requesting clarification, annotation changes or further research: 3

– Organizations: 3 

(CROPP Cooperative; OMRI; QAI)
Examples – NOSB meeting Oct 2012

Crops Subcommittee Presentation

205.601(b)(2)

(A)(2) showing at least 90% biodegradation absolute or relative to microcrystalline 

cellulose in less than two years, in soil, tested according to ISO 17556 or ASTM 5988

• BPI: Although sometimes used as synonyms, the terms “biodegradation” and 

“mineralization” are different. The 90% threshold value required by the petition and 

ASTM test methods refer to mineralization. A complete biodegradation is inferred 

when a mineralization level of 90% is reached.

• CFS: Concerned whether the tests have been adequately field verified; the TR did not 

address these questions. 10% of the mulch is allowed to remain in the microbial 

biomass or as an undegraded or partially degraded residue in soil; concerns for 

persistence in farm environment.

• OMRI: This language can serve as an appropriate and adequate review without A(1). 

5988 is a testing method, rather than a standard to which certification can be 

obtained; concerned about certifier expertise to determine if materials meet the 

annotation. A(2) & (E) conflict over the 2 year &/or end of each growing season 

biodegradation timeframe.

• PCO: there are too many standards referenced in the annotation.
Examples - NOSB meeting Oct 2012

Crops Subcommittee Presentation 

Concern Response

Short and long-term impact of 

pigments on ecosystem

Only titanium dioxide and carbon black are 

being petitioned. Titanium dioxide is nonsynthetic and would be allowed anyway, and 

carbon black is pure carbon and in effect 

already allowed as the main component of the 

ink in newspaper mulch 

Can metal catalysts build up in 

the soil and with what impacts? 

An important part of meeting the ASTM 6400 

standard above is to verify that any substances 

such as catalysts break down completely along 

with the other ingredients. All additives will be 

tested for by the MRO or the manufacturer.

Are there other additives or 

processing aids that have 

potential negative impacts? 

Same comment as above. Additionally, one of 

the makers of PLA bioplastic stated that the TR 

was inaccurate about the solvents used to 

produce PLA. No solvents are used for PLA.
Example – included in final NOSB review

Since the original recommendation dated September 1, 2009 

was posted, the NOSB has received 9 comments related to the 

Handling Committees original recommendation. Comments 

were received from organic manufacturers, certifiers, trade 

associations, and consultants to the organic industry. All 

comments disagree with the September 1, 2009 

recommendation, stating that this substance is still a necessary 

additive to boiler feed water of some organic operations to 

minimize corrosion of boilers and steam lines, especially for 

manufacturers who run predominantly organic products, and 

whose facilities are located in areas where water quality is 

exceptionally poor. There were no comments posted that agreed 

with the Handling Committees original decision. 

USDA Agricultural Marketing Service | National Organic Program 41

Nov. 2009 Handling Committee

Sunset Review of Octadecylamine
Comments

• Importance of Acknowledging 

Comments

– There will always be disagreements

– Public can accept they will not always 

get their desired outcome

• If they are not ignored

• If the reasons are explained

– Results in more consensus, and 

stronger program in the long run

USDA Agricultural Marketing Service | National Organic Program 42
Evaluation of Comments

• Questions?

• Other ideas or tips? 

• What works for you?

USDA Agricultural Marketing Service | National Organic Program 43
USDA Agricultural Marketing Service | National Organic Program 44
USDA Agricultural Marketing Service | National Organic Program 45
USDA Agricultural Marketing Service | National Organic Program 46
National Organic Standards Board 

Training: 

Operating Guidelines 

Agricultural Marketing Service | National Organic Program 

February 2017

USDA Agricultural Marketing Service | National Organic Program 1
Topics 

• Nominations Process Overview 

• Charter Renewal Overview 

• Work Agenda Development 

• Subcommittee Management 

• Public Meeting Agenda 

• Public Meeting Management 

• FOIA Review 

USDA Agricultural Marketing Service | National Organic Program 2
Nominations Process Overview

The Board nomination process takes about 1 year: 

1. Prepare Federal Register call for nominations 

and outreach plan; complete clearance process 

2. Announce call for nominations – we target a 2 

month long recruitment period 

3. Review applications for completeness and basic 

qualifications, i.e., fit with OFPA categories

4. Vet qualified candidates against exclusion 

criteria (examples: registered lobbyist; service 

on other Board)

USDA Agricultural Marketing Service | National Organic Program 3
Nominations Process Overview

6. Interview qualified and vetted candidates

7. Prepare slate and information summary about 

qualified and vetted candidates for Secretary’s 

consideration

8. Secretary selects appointee(s); appointee(s) 

announced 

9. Term begins in January 

USDA Agricultural Marketing Service | National Organic Program 4
Nomination Process Criteria 

A range of factors are considered in evaluating applicants: 

– OFPA categories of seats to be filled – mandatory 

– NOSB Recommendation on Criteria for Board 

Membership (1999) – More on this next slide! 

– Ability to work collaboratively with other Board 

members and USDA

– Ability to represent all racial and ethnic groups, 

women and men, and persons with disabilities. 

USDA Agricultural Marketing Service | National Organic Program 5
NOSB Recommendations on Nominations 

Evaluation Criteria 

• In 1999, NOSB recommended criteria for Board 

membership – these criteria are on NOP’s nominations 

webpage, are in Federal Register announcements, and are 

used during candidate evaluation. 

• Criteria include: 

– Understanding of organic principles and practical 

experience in the organic community; 

– Experience in public policy; 

– Commitment to organic integrity; 

– Ability to evaluate technical information; 

– Willingness to commit time and energy needed;

– Demonstrated experience and interest in organic 

production and certification

USDA Agricultural Marketing Service | National Organic Program 6
Charter Renewal Overview 

• FACA requires that the NOSB charter be considered 

for renewal every two years.

• This involves review by USDA and the General 

Services Administration (GSA) (oversees FACA across 

agencies) in order to revalidate the need for the 

Board and its overarching governance. 

• USDA releases Federal Register Notice announcing 

its intent to renew the Board’s charter. 

• This is a process that occurs between USDA and the 

GSA – the Board and public are not involved. 

USDA Agricultural Marketing Service | National Organic Program 7
Work Agendas: Background

1. AMS establishes the work agenda with input from the 

NOSB.

2. Board may propose ideas, but should not start work on 

new topics without NOP approval 

3. The public has a voice in this process: 

– Public may petition additions or deletions from the 

National List.

– Public may also submit comments to the Board and 

write to the NOP. 

4. FACA requires that agencies effectively use resources: 

we shouldn’t ask for advice we can’t act on.

USDA Agricultural Marketing Service | National Organic Program 8
Work Agendas: Criteria for Adding Items

1. Within Scope: Item must be within the scope of 

OFPA and within agency authority.

2. USDA/NOP Priority: Item must be a priority for the 

USDA/NOP; and something that the NOP is able to 

implement in a reasonable timeframe. 

3. Clear Need: Item must reflect a clear need for the 

NOP and/or organic community, for which 

information or advice is needed. (If it is a need, but 

NOP has enough information, it doesn’t need to be 

on the work agenda.) 

4. Clear Scope: NOP must have a clear sense of the 

intent and scope of the work agenda item. 

USDA Agricultural Marketing Service | National Organic Program 9
Work Agenda Development

The Work Agenda establishes subcommittee scope for 

the upcoming semester or year. Process: 

1. NOP develops list based on substance evaluations 

(e.g., petitions, sunset) and formal requests (via 

memos) that NOP has provided NOSB. 

2. NOP and Executive subcommittee review work 

agenda.

3. NOP approves final work agenda. 

USDA Agricultural Marketing Service | National Organic Program 10
Subcommittee Management 

• Subcommittees hold conference calls between 

public meetings to work on work plan items. 

• Effective facilitation by the subcommittee chair 

elicits different questions and perspectives, while 

keeping the group focused and on task. 

• Helping keep each other on point may help reduce 

time needed – regularly ask “what is our goal, and 

how does this discussion support the outcome we 

are trying to achieve?”

• Subcommittee notes maintained by NOP and posted 

on-line.

USDA Agricultural Marketing Service | National Organic Program 11
Discussion Documents/Proposals:

Criteria for NOP Acceptance 

1. Within NOSB Scope: Item must have been within scope 

to be on work agenda; content of product must also be 

within scope of OFPA and agency authority.

2. Implementable: Item must have been an NOP priority to 

be on work agenda; content of completed product must 

be something that NOP can actually implement if a 

recommendation is accepted.

3. Requests for Public Comment: Public comment is vital in 

shaping advice; requests must be within NOP/OFPA 

authority and not conflict with current statute and rules.

4. Quality and Clarity: Document must be clearly written. If 

two opinions or a minority opinion are included, the 

motion being voted on must be very clear. 

USDA Agricultural Marketing Service | National Organic Program 12
Public Meeting Agenda 

• Public meeting agenda prepared by NOP, driven by 

several factors: 

– Inclusion of work agenda items that have yielded 

discussion documents or proposals 

– Reasonable time for public comments 

– Time for presentations and expert panels 

– Cost

USDA Agricultural Marketing Service | National Organic Program 13
Substantive Changes at Public Meetings

• Only minor adjustments to discussion documents and 

proposals will be allowed before voting. 

• Consider the extent to which: 

• A reasonable person affected by the recommendation 

would have understood that the published proposal 

affects his or her interests;

• The recommendation’s content is substantially different 

from the proposal’s content; and

• The effects of the recommendation differ from the effects 

of the proposal.

• The NOP Deputy Administrator or designee will determine if 

a proposed amendment is a substantive change. If public 

comments lead to substantive changes, the document goes 

back to subcommittee. 

USDA Agricultural Marketing Service | National Organic Program 14
NOSB Meeting Ground Rules

Board members request of the audience:

• We ask commenters to focus on issues, not people. 

• No questions or comments from the audience 

unless invited by the Board Chair.

• Commenters may not interrupt each other or step 

in for each other without the Chair’s permission. 

• Any sidebar conversations or commenter 

preparation activities must happen out in the 

hallway, to prevent disruption and the ability of 

others to hear what’s going on. 

USDA Agricultural Marketing Service | National Organic Program 15
FOIA/FACA Overview: 

Rules of the Road on Records Release 

February 2017

USDA Agricultural Marketing Service | National Organic Program 16
FOIA/Government in the Sunshine 

• The Freedom of Information Act (FOIA) gives people 

the right to access information from the federal 

government. 

• FACA notes: “The records, reports, transcripts, 

minutes, appendixes, working papers, drafts, studies, 

agenda, or other documents which were made 

available to or prepared for or by each advisory 

committee shall be available for public inspection and 

copying at a single location in the offices of the 

advisory committee or the agency to which the 

advisory committee reports.“

USDA Agricultural Marketing Service | National Organic Program 17
Most of What You Write is OPEN 

• NOSB records (your emails and your work) are subject 

to public inspection, following agency review.

• AMS will redact confidential business information, 

private email accounts, private phone numbers, and 

cell phone numbers. Work phone numbers, fax 

numbers and email addresses, are releasable. 

• Board member’s opinions, exclamations, jokes, or 

other personal statements are likely to be released.

USDA Agricultural Marketing Service | National Organic Program 18
AMS Review Essential:

Do Not Share NOSB Documents/Email 

• NOSB communications (e.g., emails) and draft documents 

(e.g., draft proposals) must be available to the public: 

through the agency that oversees the FACA Board.

• NOP is the custodian of all Board records, so only AMS/NOP 

can make records available to requesting parties. AMS/NOP 

reviews all records before release, to determine whether 

any exemptions apply (e.g., personal information, 

confidential business information). 

• Board members may speak with community members 

about the work being done by the Board, and ask for input. 

• No Board communications or documents are to be 

forwarded or shared with any individuals or 

constituencies outside the Board members and AMS/NOP. 

USDA Agricultural Marketing Service | National Organic Program 19
Best Practices 

• Avoid sending full mail strings when responding or 

forwarding emails, unless relevant to discussion. 

• Send only the information that is necessary to 

convey your message. 

• Informality is natural, AND, watch what you state in 

your emails. Personal jokes and remarks usually 

cannot be redacted.

• Mark all drafts with watermarks or “DRAFT” in the 

header within the document.

• Do not circulate “drafts” outside of the NOSB.

USDA Agricultural Marketing Service | National Organic Program 20
Questions/Discussion 

Agricultural Marketing Service | National Organic Program 

February 2017

21